FDA.reportPublic FDA data

Vive Precision

Primary DI
00818323024616
Brand
Vive Precision
Company
VIVE HEALTH LLC
Model
DMD1038GRYL
Device description
Blood Pressure Monitor Replacement Cuffs Large
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171889000Reusable Blood Pressure CuffSuzhou Minhua Medical Apparatus Supplies Co., Ltd.2017-12-19DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818323024613PackageGS180In Commercial Distribution
00818323024616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081832302461310818323024613
00818323024616008183230246168183230246160818323024616

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226440487ViveSUP3167GRYXS2026-07-13
00810226440494ViveSUP3167GRYS2026-07-13
00810226440500ViveSUP3167GRYM2026-07-13
00810226440517ViveSUP3167GRYL2026-07-13
00810226440524ViveSUP3167GRYXL2026-07-13
00810226440531ViveSUP3167BGEXS2026-07-13
00810226440548ViveSUP3167GRYS2026-07-13
00810226440555ViveSUP3167GRYM2026-07-13
00810226440562ViveSUP3167GRYL2026-07-13
00810226440579ViveSUP3167GRYXL2026-07-13
00810226441019ViveSoleINS1014PUR2026-07-13
00810226441026ViveSoleINS1014PURS2026-07-13
00810226441002ViveLVA3171WHT2026-07-08
00818323025538ViveMOB1025BLU2019-03-07
00818323025545ViveMOB1025SLV2019-03-07
00810178887750Vive PrecisionDMD1097O28G2026-06-26
00810178887767Vive PrecisionDMD1097O30G2026-06-26
00810178889952ViveLVA3163BLK2026-06-10
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931973438504CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438511CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973438528CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973454689CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456737CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456744CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456751CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456768CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456775CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456782CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456799CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456805CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456812CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456829CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456836CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456843CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456850CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456867CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456874CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456881CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456898CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456904CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456911CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456928CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456935CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456942CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456959CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456966CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456973CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456980CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09